Durability of Two Skin Barrier Protectants (SBP)

An Evaluation of the Skin Protection Characteristics of Two Commercially Available Skin Barrier Protectants

The current study will evaluate the duration of wear and durability of two commercially available SBPs: Medline Marathon® XL (extra long) No Sting Cyanoacrylate Skin Protectant (henceforth referred to as "Marathon®") and 3M™ Cavilon™ Advanced Skin Protectant (henceforth referred to as "Cavilon™").

Study Overview

• Status: Completed
• Conditions: Skin Hydration in Healthy Volunteers
• Intervention / Treatment: Device: Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant

Detailed Description

Completion of informed consent and participant screening will be followed by a washout period of minimum 18 hours (wherein participants will be asked to avoid application of cleansers, lotions, or perfumes to both forearms and inner elbows) prior to the first visit (Visit 1) of the study. During Visit 1, study personnel will confirm that the washout period has been successfully completed. Participants will wash their forearms and inner elbows with a standardized soap and dry them using paper towels for each arm. After the participants' forearms and inner elbows have fully dried, study personnel will use a Corneometer® (which measures skin hydration) to record baseline measurements of the skin within 2-inch x 2-inch squares (starting about two inches above the wrist) marked with a non-toxic marker on the volar forearms and inner elbows of the participants. Thereafter, participants will be randomized to the two SBPs, Marathon® or Cavilon™ (designated SBP). The designated SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's dominant arm (as determined by the participant). The other SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's non-dominant arm. A distinct area of each volar forearm will be used as an "untreated control area". Corneometer® measurements will be taken again on the same day after the SBPs have been left to dry for at least one minute or have fully dried. Thereafter, subsequent measurements will be taken daily over a seven-day period with a two-day break over the weekend. Each participant will commence the study on Monday or Tuesday. This will permit daily readings for the first 72 hours, which is the more important window to evaluate SBP wear time. There will be a two-day break in measurements over the weekend, after which Corneometer® measurements will be taken either on Monday, or Monday and Tuesday, depending on the participants' start date. Participants will be allowed to bathe their arms using a standardized soap provided by the study personnel but will be asked to minimize scrubbing and any other abrasion of the volar forearms and inner elbows. In addition, participants will be instructed not to engage in activities, for eg, sports (eg, tennis) or holding a baby that may cause significant abrasion on one arm and not the other. On the last visit of the study (Visit 6), study personnel will take the last set of Corneometer® measurements. In addition, participants will also complete surveys regarding their experience with the SBPs on specific days during study participation.

The Corneometer® measurements will help determine the presence of the SBPs and their deterioration over time. Skin treated with the SBPs will typically have lower readings than untreated skin. As the SBPs break down, the corresponding readings are expected to rise.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Northfield, Illinois, United States, 60093
      • Medline Industries, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individuals ≥ 18 years of age

Exclusion Criteria:

• Individuals have skin conditions that might interfere with Corneometer® measurements, including rash, irritation, sunburn, tattoo, birthmark, any other dermal irregularities on the left or right volar forearm or inner elbow.
• Individuals have excessive hair on the left or right volar forearm or inner elbow as determined by study personnel.
• Individuals have a self-reported allergy/sensitivity to ingredients present in either of the SBPs, components of the soap used for bathing, or the exam gloves and non-toxic marker used in the study.
• Individuals are pregnant.
• Individuals whose self-reported activities may affect friction on one arm more than the other (eg, sports like tennis or holding a baby where one arm is used more routinely than the other).
• Individuals who are able to identify the manufacturer of the SBPs included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: receives both product; all participants receive both products under evaluation.	Device: Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant; All participants will receive both device interventions listed above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration	To evaluate the duration of wear of Marathon® and Cavilon™ using the Corneometer® CM (capacitance method) 825 taking measurements of the skin (in Arbitrary Units) with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.	7 Days - Baseline + 6 visits = 7
Durability	To evaluate the durability of Marathon® and Cavilon™ using the Corneometer® CM 825 taking measurements of the skin (in Arbitrary Units) in the inner elbow location with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.	7 Days - Baseline + 6 visits = 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Feedback 2	To collect information on the participant experience with the two SBPs (Skin Barrier Protectants) using survey results (5 point scale from very comfortable to very uncomfortable). This question was on assessed at visit one.	1 day
Participant Feedback	To collect information on the participant experience with the two SBPs using survey results (yes/no questions). This measurement collected on visit thee and visit six.	2 Days
Participant Feedback - Product Preference	Collect participant feedback on which arm is it easier to determine the skin barrier protectant is present?	7 Days - Baseline + 6 visits = 7

Collaborators and Investigators

• Sponsor: Medline Industries
• Investigators: Principal Investigator: Julie Miller, Medline Industries, LP

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents
• Other Study ID Numbers: MED-2022-DIV71-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No